Study Design

Before Starting New Medications

﻿EligibilityThe patient has been on methotrexate alone for 3 months and does not feel better. His or her doctor recommends the two treatment options as equally effective. Having heard of the trial, the patient would like to enroll.

Screening | Week -2The patient goes to the study site for the first visit to confirm their interest and eligibility. The study doctor explains the trial and answers questions, and the patient agrees to participate. Then, the patient answers questions about their health history and has a joint count, a physical exam, and a blood draw.

First FDG-PET/CT Scan | Week -1Once the patient has been cleared to participate, she goes to the imaging center for her first (baseline) scan. There, they have a blood draw to check for high blood glucose levels and pregnancy, if applicable. The patient is injected with a tracer for the scan, then lies in the scanner for 20 minutes. The scanner is similar to a CAT scan, with the patient's head and feet sticking out of the ends. After the scan, the tracer breaks down and becomes glucose.

﻿Starting New Medications

Baseline Visit | Week 0The type of scan used, an FDG-PET/CT, can detect cancerous tissues, so the imaging team reads the scan to confirm everything is fine. The patient returns for their baseline visit, where they find out which treatment they will be taking. If the patient is on triple therapy, they will receive a supply for the next six months. If the patient is taking a biologic DMARD (Enbrel or Humira), they will receive a supply to last them through Visit 5 (Week 18), at which point more medications will be ordered for them. They then have a joint count, give a blood sample, and answer questions about their physical activity and demographics.

After Starting New Medications

Visit 3 | Week 6After six weeks on the study drug, the patient returns for a follow-up visit. They have a joint count, a blood pressure reading, and a blood draw.

Visit 4 | Week 12The patient goes back for their next follow-up visit. They have a joint count, their blood pressure is taken, and they answer questions about any medications they have started.

Visit 5 | Week 18At the fifth study visit, the patient has a joint count done and blood drawn. The study doctor talks to the patient about how they are feeling. If the patient's RA symptoms are still moderate or severe, the study doctor switches some of their medications for the rest of the trial.

Second FDG-PET/CT Scan | Week 22The patient goes back to the imaging center for the final FDG-PET/CT scan. After a blood draw to check blood glucose and potential pregnancy, they get their final scan.

Visit 6 | Week 24After six months on the trial, the patient meets with the study doctors for the last time. They get a joint count, have their blood pressure taken, and have their last blood draw. After answering some final questions, they are done with the trial!